Infections, MeningococcalPhase 3NCT00514904
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
A Phase 3 study testing Nimenrix and Mencevax in people with Infections, Meningococcal and Meningococcal Vaccines, run by GlaxoSmithKline at 7 sites in 4 countries.
Trial summary
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal, Meningococcal Vaccines
- What is being tested?
- Nimenrix and Mencevax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,504 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 18 Sep 2007to 6 Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 2 and 10 years of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
Show all 12Show fewer
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
India4 sites
GSK Investigational Site
Goa, 403202
GSK Investigational Site
Indore, 452001
GSK Investigational Site
New Delhi, 110002
GSK Investigational Site
Vellore, 632004
About this study
Official title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
- Conditions
- Infections, Meningococcal, Meningococcal Vaccines
- Being tested
- Nimenrix, Mencevax
- Keywords
- safety, meningococcal vaccine, immunogenicity
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimenrixBiological
Also called Meningococcal vaccine GSK134612
Single dose, intramuscular injection
MencevaxBiological
Single dose, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix Group | Experimental | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: Nimenrix |
| Mencevax ACWY Group | Active comparator | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. Receives: Biological: Mencevax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Measured: One month after vaccination (Post-vaccination, study Month 1)
Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
Measured: During the 4-day (Days 0-3) post-vaccination period
Secondary outcomes (13)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.
Measured: Pre vaccination (Month 0) and post vaccination (Month 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Antibody titers were expressed as geometric mean titers (GMTs).
Measured: Pre vaccination (Month 0) and post vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.
Measured: Pre vaccination (Month 0) and post vaccination (Month 1)
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs)
Measured: Pre vaccination (Month 0) and post vaccination (Month 1)
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
Measured: Pre vaccination (Month 0) and post vaccination, (Month 1)
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
Measured: Pre vaccination (Month 0) and post vaccination (Month 1)
Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects < 6 Years of Age With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
Measured: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
Measured: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects Reporting Specific Adverse Events (AEs)
Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.
Measured: From Day 0 up to 6 months after vaccination
Number of Subjects Reporting Any Unsolicited Symptoms
Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: Up to one month (Day 0-Day 30) after vaccination
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
Measured: From Day 0 up to 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study start18 Sep 2007
- Primary completion3 Sep 2008
- Study completion6 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514904
- Sponsor's protocol ID
- 109495
- Other IDs
- 2012-000283-23
- Status last verified
- Sep 2020
- First submitted
- 9 Aug 2007
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02.
PubMed 21278617
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
- ClinicalTrials.gov ID
- NCT00514904
- Acronym / sponsor ID
- 109495
- Conditions
- Infections, Meningococcal, Meningococcal Vaccines
- Keywords
- safety, meningococcal vaccine, immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2007 (actual)
- Primary completion
- 3 Sep 2008 (actual)
- Study completion
- 6 Jan 2009 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimenrix Group | Experimental | Biological: NimenrixSubjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Mencevax ACWY Group | Active comparator | Biological: MencevaxSubjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 2 and 10 years of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimenrixAlso: Meningococcal vaccine GSK134612Single dose, intramuscular injection | Biological | Nimenrix Group |
| MencevaxSingle dose, subcutaneous injection | Biological | Mencevax ACWY Group |
Primary outcome
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
Time frame: One month after vaccination (Post-vaccination, study Month 1)
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
Time frame: During the 4-day (Days 0-3) post-vaccination period
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
13 secondary outcomes
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Time frame: Pre vaccination (Month 0) and post vaccination, (Month 1)
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects < 6 Years of Age With Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Number of Subjects Reporting Specific Adverse Events (AEs)
Time frame: From Day 0 up to 6 months after vaccination
Number of Subjects Reporting Any Unsolicited Symptoms
Time frame: Up to one month (Day 0-Day 30) after vaccination
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: From Day 0 up to 6 months after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21278617Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimenrix and Mencevax in people with Infections, Meningococcal and Meningococcal Vaccines, run by GlaxoSmithKline at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India, Lebanon, Philippines, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 (time frame: One month after vaccination (Post-vaccination, study Month 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.